Ampoules, vials, etc. in aseptic filling units. OQ and PQ studies of the tunnels used for the depyrogenization process after the washing process of the containers are carried out.

Performance evaluation is carried out after the approved installation and operational qualification of the tunnels.

The OQ study is performed to understand the state of the temperature distribution while the tunnel is hollow and provides data on the structure and performance of the tunnel. In addition, the filter, differential pressure, air velocity and air class should also be checked. Of course, sensor calibrations must also be done.

PQ work can be used for vials, ampoules, etc. carried out with product containers. In particular, the entrance of the products into the tunnel, its continuation and the end of the process should be simulated. Conveyor speed, washing machine speed etc. is of critical importance. Guidelines for depyrogenization require min.250 degrees and min.Fd:30 min. Generally, tunnels are required to operate at 300 degrees and above set values.